Follicle-stimulating hormone (FSH) is a gonadotropic hormone (GTH) and is involved in the growth of seminiferous tubule and the promotion of semen formation in testis and, in ovary, in the growth and maturation of follicle.
The diseases associated with high amount of FSH in blood included climacteric disturbance (e.g. Hyojunsanfujinkagaku: ISBN: 4260130536, Igakushoin Co., Ltd., Change of Sexual Function and Sexual Organ Form with Aging, p. 23 to 25, 1997). Besides, there are primary hypogonadism, Turner's syndrome, Klinefelter' s syndrome, gonadotropin-producing tumor, testitis (e.g. Naikashindangaku: ISBN: 4890132341, Hormone Test, Nishimurashoten, Niigata, p. 843 to 887 1997), primary ovarian amenorrhea, hormone-producing tumor (e.g. Hyojunsanfujinkagaku: ISBN: 4260130536, Igakushoin Co., Ltd., Emmeniopathy B Amenorrhea, p. 34 to 44, 1997), etc.
Description is made on climacteric disturbance which is one of the above diseases.
Climacteric is defined in various ways but it refers to several years before and after menopause. Those diseases which appear in this period, are unbearable physically and mentally and need treatment, are called climacteric disturbance or disorder (e.g. M. Mizuno, Psychosomatic Disorder, Climacteric Disturbance and Health Care of Middle-Aged and Elderly Women, Hyojunsanfujinkagaku: ISBN: 4260130536, Igakushoin Co., Ltd., Tokyo, p. 170 to 175, 1997).
Climacteric disturbance appears in various symptoms and is largely divided into (1) dyshormonism such as metrorrhagia and atrophied vaginitis, (2) vasomotor nerve system disturbance such as burning sensation and palpitation, (3) psychomotor nerve system disturbance such as heaviness of head, headache and dizziness, (4) motor system disturbance such as stiff shoulder and lumbago, (5) digestive system disturbance such as constipation, inappetence and nausea, (6) urinary system disorder such as thamuria and sense of residual urine; (7) disorder of dermatologic system, internal medicine and urologic system such as perspiration and sense of oral dryness, (8) metabolism disturbance such as emaciation and obesity, (9) perception system such as numbness, and (10) other disturbances (e.g. Hyojunsanfujinkagaku: ISBN: 4260130536, Igakushoin Co., Ltd., Tokyo, 1997) As representative symptoms of the climacteric disturbance, there are known dizziness, indefinite complaint, headache, palpitation, etc. As psychogenic symptoms often seen in the climacteric disturbance, there can be mentioned depression, masked depression, generalized anxiety disorder, panic disorder, somatoform disorder, disorder of estrogen secretion, symptoms of the castrates, etc.
As the therapy for climacteric disturbance, various drug therapies can be mentioned.
Representative of such drug therapies are hormone replacement therapy (HRT), antianxiety drugs and anti-depressants. Meanwhile, there are times that traditional Chinese herbal medicines are used for before-menopause cases wherein menstrual cycle still remains at a certain level, or for postmenopause cases wherein HRT is contraindicated or is not desired. As main Chinese herbal medicines, there can be mentioned Toki-syakuyaku-san, Kami-syoyo-san and Keishi-bukuryo-gan (Current Diagnosis and Treatment, 12th Edition). Tsudo-san which is used only for removal of Oketsu (blood-stasis) in climacteric disturbance, contains a small amount of Carthamus tinctorius but the main component thereof is Japanese angelica root (e.g. T. Tani, Efficacy and Pharmacography of Traditional Chinese medicines, Chapter 17 Crude Drugs for Amelioration of Emmeniopathy, Nanzando Co., Ltd., Tokyo, p. 159 to 168, 1992; S. Koyama, Medical Herbal Extracts of East Asia: A Materia Medica Based on the Classics: ISBN: 4-901767-04-6 C3047, Tsudo-san, Medical Yukon Co., Ltd., Kyoto, p. 453 to 457). It is known that an efficacy for endocrine function is expected by use of Toki-syakuyaku-san (an agent for increasing FSH, LH and progesterone), Keishi-bukuryo-gan (an agent for increasing FSH and LH), Syakuyaku-kanzo-to (an agent for increasing progesterone and testosterone), Unkei-to (an agent for increasing LH-RH and an agent for reduction progesterone), and the like. (e.g. Guideline for Treatment by Traditional Chinese medicines, Obstetric and Gynecological Diseases, Outline of Obstetric and Gynecological Diseases, Midori Shobo Co., Ltd., Tokyo, p. 375 to 426).
Meanwhile, as to Cucurbita moschata, Carthamus tinctorius, Plantago asiatica and Lonicera japonica, respective efficacies are reported as follows. For example, it is disclosed that addition, to a feed, of at least one kind of Cucurbita moschata, Plantago asiatica and Lonicera japonica (particularly, a crude drug comprising these three crude drugs) can prevent, in particular, natural infection of parasites, bacteria and viruses and can achieve higher biophylaxis ability and improved meat and egg qualities. Further, it has been disclosed that a feed comprising four kinds of crude drugs, i.e. Cucurbita moschata, Plantago asiatica, Lonicera japonica and Carthamus tinctorius improves the health conditions, survival rates, quality of egg, and has anti-leucocytozoonosis effect in layers, and anti-New-Castle-disease effect and effects of the decreased numbers of enteric Coccidium and Staphylococcus in the intestine of quails (e.g. U.S. Pat. No. 5,882,672).
A method for producing an interferon inducer from the plants of the genus Cucurbitaceae such as pumpkin has been disclosed (e.g. U.S. Pat. No. 4,421,746). The antiviral activity and anti-tumor activity of interferon inducers extracted from the flowers of Carthamus tinctorius has been disclosed (e.g. U.S. Pat. No. 4,456,597). It has also been disclosed that interferon inducers may be extracted from the flowers of Lonicera japonica, seeds of Plantago asiatica, and the like, and that the extracted interferon inducers are useful for prevention and curative treatments of viral infections in humans and animals (e.g. U.S. Pat. No. 4,469,685). A macrophage activator comprising two crude drugs of Cucurbita moschata and Carthamus tinctorius has also been disclosed (e.g. Japanese Patent Laid-open No. 116498/1999). A neutrophil activator comprising four crude drugs of Cucurbita moschata, Carthamus tinctorius, Plantago asiatica and Lonicera japonica has also been disclosed (e.g. Japanese Patent Laid-open No. 281584/2000).
However, while these documents disclose the interferon inducing effects, macrophage activating effects, neutrophil activating effects, the inhibitory effects of IgE anti-body production, and the like of the crude drugs used as active components in the present invention, none of the references disclose or suggest the effect of reduction FSH level in high FSH concentration in blood.